US Regulatory Roundup – September 2022: Philips Troubles, Software And User Fees
The ten most popular stories about US regulatory issues published by Medtech Insight last month were a mixed bag, with a Philips recall taking the top spot and stories about AI, user fees, and more adding to the list.
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Passed by the US House and signed into law on 30 September, the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023, avoids a partial government shutdown and furloughs in FDA user-fee programs including MDUFA. Policy riders stripped from the legislation, including for FDA oversight of lab-developed tests, could still find their way into a final FY 2023 spending omnibus.
News We’re Watching: Biden Moves To Strengthen Supply Chain; More Medtech-Related Prosecutions; $5.5M Sepsis Grant For Siemens
This week, the Biden administration announced a new council on supply chain resilience that includes health care goals; an apparent enforcement surge against device fraud continued; Siemens won a $5.5m grant to develop a better sepsis test; and the FDA proposed new classifications for wound care products.
In this wide-ranging interview, lawyer Philip Desjardins talks about regulatory issues from AI to LDTs – as well as the passion for patient health that keeps him in the medtech arena.